Compression Machine FAT (Factory Acceptance Test)

Compression Machine FAT (Factory Acceptance Test)

Compression Machine FAT – The purpose is to identify the quality acceptance tests performed at the suppliers’ facilities. Ensuring the compression runs well at startup is an important role of the equipment supplier. Proper design and fabrication are critical, but equally important is a full shop performance test. performs a factory acceptance test on every compressor and dispenser we ship at the operating suction and discharge pressures at the site. also check control functions, wiring connections, compressor skid vibration, flow rates, and electrical loads.

Machine Name: 35 STN “B” TOOLING TAB, COMPRESSION MACHINE

Document Name: Factory acceptance test

Table of Contents of Compression Machine FAT

  • SYSTEM DESCRIPTION
  • SYSTEM CHECKS
  • Physical Check
  • Basic Component Verification
  • VERIFICATION OF SAFETY AND INTERLOCK FEATURE
  • FUNCTIONAL VERIFICATION
  • Basic Challenge Test
  • ACCESS LEVEL SECURITY
  • TRAIL REPORT

PERFORMANCE QUALIFICATION FOR TABLET COMPRESSION

SYSTEM DESCRIPTION: The major components of the equipment are identified us:-

  • Powder Feeding unit.
  • Powder transfer unit
  • Compression unit
  • Hydraulic power pack assembly
  • Discharge unit
  • Lubrication unit

The Tablet Compression B4 Type 35 Station. “B” Tooling Tab, Machine, supplied by ______________, a double rotary high-speed tablet press, is a machine incorporated with the force-feeding arrangement, auto-lubrication, electromagnetic clutch, power level sensor, and rejection/sampling port.

The powder feeding unit has an S.S. 316 Hopper capacity of 16 Liters. rests on top of the machine which holds the powder in it and delivers to the feeding assembly through a butterfly valve which controls the flow of the powder between the hopper and the feeding assembly. The hopper consists of an agitator, which enhances the powder flow. A barrel–type powder level sensor is mounted on a bracket and fixed against the sight glass of the hopper.

The powder transfer unit Consists S.S. 316 inlet connector, which links the hopper and the force feeder, the force feeder has two counter-rotating paddles of S.S. 316, driven by a reduction gearbox and variable frequency AC drive motor. The tail over die is an essential feature of the high–speed tablet press. The function of the tail-over die is to keep the filled die covered until the last moment before the upper punch enters the die.

The drive unit has a main motor of 5HP and drives a very high reduction gearbox unit using an electromagnetic clutch and a timing belt. The gearbox unit consists of a Phosphorus bronze worm wheel and a worm shaft. The turret is a three-piece structure having the center die tablet of S.S. 316 and upper and lower pieces of cast iron of SG 400/15. The upper piece holds the upper punches, which rest on the upper cam tracks with the cam plate. Similarly, the lower piece holds the lower punches that travel on the lower cam tracks and Dozer.

The compression unit comprises an upper main pressure roll assembly having a roll center, pressure roll, and pressure roll pin. The roll center holds the pressure roll and is locked by using external circlips upper punch penetration assembly is responsible for the entry height of the upper punch in the die. Tablet thickness assembly is responsible for deciding the tablet thickness.

Weight dozer assembly is responsible for adjusting the weight of the tablet by varying the depth of fill. The depth of fill is adjusted by the upward and downward movement of the weight-adjusting head through a dozer-adjusting screw with the help of a dial.

The hydraulic power pack assembly system controls the safety overload mechanism, which governs the maximum pressure, and level, at which particular tablets are being made. The oil reservoir for this system is located in the front LH corner of the lower cabinet. It can be accessed by removing the lower side guard (LH). The oil level in the reservoir should be checked regularly through the oil level indicator.

The tablet discharge unit comprises of ejection cam, tablet scrapper assembly & tablet discharge chute. The height of the ejection cam needs to be set in such a way that the tip of the lower punch is slightly above the die to avoid tablet-chipping problems. As soon as the tablet is ejected it strikes the tablet scrapper assembly, which directs the tablet to the discharge chute. The tablet discharge chute is made S.S. 316 with an acrylic cover. Tablets slide out through this chute to the container.

Auto lubrication system is provided for the lubrication of all critical pinpoints like roll pins, it comprises a lubrication tank, a motorized pump, distribution manifold, and pipelines. This pump operates on a timer set in the PLC. It should be noted that the ON time should be less than the OFF time, to prevent oil flooding. The dozing of oil’s respective critical points can be throttled through the distribution manifold.

The lower punch lubrication system helps mainly for smooth and easy ejection of tablets. In addition, the tablet gets a clean, smooth surface on the web. The lower punch has an extractor groove below the tip for the lubrication support, which may be a lubrication felt or woolen thread winding. To avoid lubricant, the scraper mechanism is built in. The stripper oil is collected in a collecting tray. The scraper keeps the external diameter of the die plate and lower punch guide clean. From the collecting tray, the oil is transported downward through a funnel and a hose line and returned to the tank.

The working principle of compaction force control is whenever the powder is compressed from a tablet an impact is generated. The oil in the hydraulic cylinder absorbs this impact. The load cell, which is mounted between the upper roll lever and the hydraulic cylinder, senses the load received. The value is transferred to the data control screen through the MP55 transducer and the PLC. The data control screen displays the individual force of all the punches.

 SYSTEM CHECKED DURING COMPRESSION MACHINE FAT:

Physical Check : Outer Surface finish verification – Check the Outer surface of the machine

Acceptance Criteria

  • Matt finish
  • Curved corner
  • No dent
  • No visible spot of welding
  • AC/DC panel checking – Visual check 

Acceptance Criteria : Should be available ,Proper wiring

Document verification – Verification of calibration certificate of Digital Pressure Indicator and Pressure Gauge.

Acceptance Criteria -A calibration certificate should be available

Document verification – Verification of MOC certificate

Acceptance Criteria-MOC certificate should be available

Basic Component Verification : Machine Dimensions

Acceptance Criteria:1880 (L) X 2040 (W) X 2000 (H)MM: Test Method: Machine Dimensions: Acceptance Criteria fulfilled –Yes/No.

G.A. Drawing: Machine construction should meet with G.A. drawing, Visually/Via Tag, Acceptance Criteria fulfilled –Yes/No.

Main switch (ON/OFF): ON/ OFF function, Qty.: 01 no.:, Visually/Via Tag, Acceptance Criteria fulfilled –Yes/No.

Emergency switch (ON/OFF) :Make: Banner, Qty.: 1 No. , Visually/Via Tag, Acceptance Criteria fulfilled –Yes/No.

Compression Machine IQ (Installation Qualification)

ELECTRIC MOTORS (MAIN MOTOR)

  • MAKE – CROMPTON
  • RPM =1440
  • HP/KW : 5HP./3.3KW/ FOOT MOUNTED
  • PHASE : 3 PH
  • FREQUENCY:50 Hz

AC VARIABLE FREQUENCY DRIVE FOR MAIN MOTOR

  • MOTOR RATING:5 HP
  • MAKE
  • MODEL
  • SR. NO.

GEARBOX [MAIN DRIVE]

  • MANUFACTURER: FALCON
  • TYPE: WORM & TEETH RING
  • REDUCTION STAGE: SINGLE

LUBRICATION OIL PUMP

  • MANUFACTURE: DROPCO ENG
  • MODEL : DMHT-600-5 (Dx)
  • LUBRICATION SYSTEM: ONE-SHOT LUBRICATION (MANUAL HANDEL TYPE PUMP)

VERIFICATION OF SAFETY AND INTERLOCK FEATURE DURING COMPRESSION MACHINE FAT :

Emergency Stop :

Acceptance criteria

Emergency Stop Activated Alarm message should display on the monitor screen and the inspection will stop.

The tower lamp should glow with red color and the buzzer should get ON.

FUNCTIONAL VERIFICATION DURING COMPRESSION OF MACHINE FAT  :

Basic Challenge Test Compression Machine FAT:

Upper guards [when interlock mode is selected for machine function]

System Result – Open any of the upper guards

Remedial Action –

The machine will stop immediately and can not be restarted till the guard is open

Guard open indicator lamp will be “on”

Main pressure overload

System Result – Increase depth of fill and/or decrease tablet thickness either L.H.S. OR R.H.S.

Remedial Action – The main set pressure overload indicator lamp will be “on”

At the time of providing the password if the admin set the password in a non-alphanumeric nature

System Result – 

“Password should be min 8 characters and must contain at least one number, small case letter, upper case letter, and each” Message should be displayed.

Remedial Action –Provide password as per note given on system display

At the time of providing the password if the admin sets the password to less than 8 8-digit

System Result –

“Password should be min 8 characters and must contain at least one number, small case letter, upper case letter, and each” message appears on the screen.

Remedial Action – Provide password as per note given on system display

If the user expires by the date

System Result –  “USER: USER1 password has expired. Do you want to change the password”.The message should be displayed on the screen.

Remedial Action – Contact to admin and Renew the date from your admin

At the time of login if you enter 3 times wrong password

System Result – The “Your account has been locked. Please contact to admin to unlock” message should be displayed on the screen.

Remedial Action – Contact to admin and unlock the account from your account

Power Failure

System Result –The machine stopped and after resuming power should not lose the data.

Remedial Action – Power Backup Facility (UPS)

ACCESS LEVEL SECURITY:

Admin: The system should allow to creation of 30 Admin

Supervisor: The system should allow to creation of 30 Supervisor

Operator: The system should allow to creation of 50 Operator

TRAIL REPORT OF COMPRESSION OF MACHINE FAT :

Machine Operational & Performance Verification (Trial- I): 

Machine Speed (10 RPM)  /Trial – Sample #1/Sample #2/Sample #3

Weight Variation

Wt. of 20 Tablets (gm): NMT ±2% of target weight

Individual (mg) ; NMT ±5% of target weight

Friability (% w/w): NMT 1%

Hardness (Kg/cm2): NLT 2.0 Kg

Thickness (mm): To monitor

Machine Operational & Performance Verification (Trial- II) COMPRESSION OF MACHINE FAT

Machine Operational & Performance Verification (Trial- I): 

Machine Speed (15 RPM) /Trial – Sample #1/Sample #2/Sample #3

Weight Variation

Wt. of 20 Tablets (gm): NMT ±2% of target weight

Individual (mg) ; NMT ±5% of target weight

Friability (% w/w): NMT 1%

Hardness (Kg/cm2): NLT 2.0 Kg

Thickness (mm): To monitor

Machine Operational & Performance Verification (Trial- III):

Machine Operational & Performance Verification (Trial- I): 

Machine Speed (20 RPM) /Trial – Sample #1/Sample #2/Sample #3

Weight Variation

Wt. of 20 Tablets (gm): NMT ±2% of target weight

Individual (mg) ; NMT ±5% of target weight

Friability (% w/w): NMT 1%

Hardness (Kg/cm2): NLT 2.0 Kg

Thickness (mm): To monitor

SUPPLIER & CLIENT REMARK:

SUPPLIER REMARK :___________________________(Sign/date)

CLIENT REMARK:___________________________ (Sign/date)

Compression Machine IQ (Installation Qualification)

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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